For manufacturers in fast-paced industrial environments, risk management is a top priority. In the pharmaceutical space, human error poses daily risks that affect operations and could impact compliance with good manufacturing practice (GMP) requirements. If not carefully managed, one such area of risk has the potential for dangerous results—both for your business and your customers.
Your customers trust your organization to deliver a quality product. These relationships—and human safety—rely on your organization’s ability to uphold high standards for washing equipment. Even if your company can control almost every variable in the washing process (such as time, temperature, chemical reactions, coverage, etc.), the potential for human error could still have costly results. In addition to the inconvenience and expense of rewashing and time loss, improper washing impacts regulatory compliance, customer trust, and most of all, patient health and safety.
“The worst that could happen is if processed parts were reintroduced on the production line, and if those parts get contaminated, a consumer could take a pill or an injection and potentially get really ill, or even die. So it’s really serious.”
—Olivier Van Houtte, Senior Manager for Product Marketing in the Life Sciences Division of STERIS
With your organization’s reputation and patient safety at stake, it’s critical that washing procedures are followed. But washing equipment isn’t immune to errors—whether they result from people, products, or processes. Ensuring correct, complete washing should start at the beginning of the washing process with standard operating procedures (SOPs). However, many pharmaceutical manufacturers rely on static or paper-based SOPs. These often lack critical context, forcing the user to fill the gaps. Inadequate SOPs introduce opportunities for human error—which means a batch could be compromised early in the washing process.
“Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s & warning letters from the FDA.”
—Better, Faster, Easier SOPs: Improving Standard Operating Procedures with Augmented Reality
To prevent incorrect washing from impacting patient outcomes, organizations must explore solutions that help manage the risk, including alternatives to traditional SOPs. When used to transform SOPs, augmented reality (AR) streamlines and accelerates employee efficiency and accuracy by:
When faced with the responsibility to improve upon traditional SOPs, one life sciences business found the solution in AR.
STERIS, a global leader in infection prevention technologies, discovered that guided work instructions could transform its traditional SOPs. Working with PTC and ITC, a services partner, STERIS created the Smart AR Loading Technology application. By supplying its customers with tablets, which have the application, STERIS now delivers clear, contextualized AR content to guide them as they load washing racks.
Transforming SOPs is critical for pharmaceutical manufacturers to manage the risks of improper washing and avoid serious ramifications. In STERIS’ case, AR improves SOP delivery through instructional content that is clear, contextualized, and actionable.
Watch the recent webinar with STERIS and PTC.